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Comparison of Different Methods for Intra- and Postoperative Pain Therapy in Thoracic Surgery

NCT ID: NCT05208619

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-09

Study Completion Date

2025-04-30

Brief Summary

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The aim of the study is to determine which regional anaesthesiological technique (thoracic epidural analgesia or paravertebral block) is more suitable for thoracic surgery

Detailed Description

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Thoracic interventions (lung operations) are associated with considerable postoperative pain, whereby an open surgical procedure via a skin incision (thoracotomy) is more painful than a minimally invasive endoscopic intervention (thoracoscopy). In order to reduce pain, a regional anaesthetic is administered during the induction of anaesthesia, which reduces pain both intraoperatively and postoperatively. In thoracic surgery, thoracic epidural analgesia (PDA) and paravertebral block (PVB) are the main regional anaesthesiological measures used, although it is unclear which of the two procedures is superior in terms of efficiency and effectiveness. Particularly intraoperatively, but also to some extent postoperatively, regional anaesthesia alone is usually not sufficient for pain management. Rather, additional systemic (i.e. intravenous) analgesics (especially opioids) are administered. Therefore, the amount of these additionally administered analgesics is a measure of the efficiency of the regional anaesthesia procedure.

Conditions

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Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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thoracic epidural analgesia

A thoracic epidural catheter is placed before induction of general anaesthesia. Sufentanil 10 µg and Ropivacaine are applied via the catheter.

Group Type ACTIVE_COMPARATOR

Regional anaesthesia

Intervention Type PROCEDURE

Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery

paravertebral block

A single-shot paravertebral block (Ropivacaine 0,5%) is placed before induction of general anaesthesia.

Group Type ACTIVE_COMPARATOR

Regional anaesthesia

Intervention Type PROCEDURE

Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery

Interventions

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Regional anaesthesia

Patients receive either a thoracic epidural analgesia or paravertebral block as an regional anaesthetic adjunct to general anaesthesia for thoracic surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* elective thoracic surgery
* American Society of Anaesthesiologists (ASA) 1-3 status
* written informed consent

Exclusion Criteria

* pregnancy
* adipositas (bmi \> 30)
* cardiac arrhythmia
* coagulation abnormalities
* chronic pain
* opiate abuses
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HELIOS Klinikum Bonn/Rhein-Sieg

UNKNOWN

Sponsor Role collaborator

University Hospital, Bonn

OTHER

Sponsor Role lead

Responsible Party

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Martin Soehle

Vice Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

Bonn, , Germany

Site Status RECRUITING

Helios Klinikum Bonn/Rhein-Sieg

Bonn, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Martin Soehle, MD, PhD, MHBA

Role: CONTACT

[email protected]
++49-228-287-14127

Facility Contacts

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Martin Soehle, MD, PhD

Role: primary

[email protected]
++49-228-287 ext. 14127

Joachim Schmidt, MD, PhD

Role: primary

[email protected]
++49-228-6481-11297

Other Identifiers

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Veritas

Identifier Type: -

Identifier Source: org_study_id